Guarded imaging devices and methods

ABSTRACT

An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient&#39;s tissue with the device within a living body in association with obtaining an image of the patient&#39;s tissue, are included.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. application Ser. No.14/135,359, filed Dec. 19, 2013, which claims the benefit of U.S.Provisional Application No. 61/740,994 filed Dec. 21, 2012, each ofwhich is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

Embodiments of the present disclosure relate generally to the field ofmedical devices and, more particularly, to flexible, elongate bodies(e.g., a catheter) including imaging within a guarded zone between twoinflatable balloon assemblies, along with methods of making and usingsuch devices and systems including such devices within a living body.

BACKGROUND

Intravascular imaging systems are widely used in interventionalcardiology as a diagnostic tool for a diseased vessel, such as anartery, within the human body. Various sensors may be placed on acatheter and positioned in the body. One type of imaging system is anintravascular ultrasound (IVUS) system, which can include either asingle rotating transducer or a solid-state array of transducers.

Intravascular imaging systems are often used to detect occlusions orother materials in an artery or other vessels, which can sometimes berelieved through use of a balloon catheter or other means. A ballooncatheter is a type of catheter with a balloon near the tip. The ballooncatheter is designed to be inserted into a patient's artery or vessel,and positioned near a spot where an occlusion was detected through useof an intravascular imaging system. Upon reaching the detectedocclusion, the balloon is inflated to relieve the occlusion. In someinstances, the balloon catheter includes a stent, and inflation of theballoon expands and deploys the stent within the vessel.

While existing catheters deliver useful diagnostic imaging information,there is a need for enhanced image quality and ease of use to providemore valuable insight into the condition of vessels and passageways invivo. Accordingly, there remains a need for improved catheter-typedevices, systems, and methods for providing a superior imaging devicewith clearer images by having fewer and smaller distortions, orspeckles, compared to those presently available. Moreover, there is aneed for imaging systems that are also capable of treating a patient'svessel in conjunction with monitoring the course of treatment, and forextending the time available to conduct more in-depth imaging ortreatment, or both.

SUMMARY

The disclosure relates to an imaging device, and in some embodiments, anintegrated imaging and treatment device, that provides two balloonassemblies that define a guarded zone between the balloons to conductimaging, treatment, or both. Alternatively, the imaging may occur inthis guarded zone while treatment occurs distal to both balloons.

In a first aspect, the disclosure encompasses an imaging device having aproximal portion and proximal end, and a distal portion and distal end,which includes: a first balloon assembly in a distal position, whichincludes a first balloon, and a first connection lumen that extends fromthe proximal portion into the first balloon to permit transfer of afluid therebetween so as to independently inflate or deflate the firstballoon; a second balloon assembly in a proximal position relative tothe first balloon assembly, which second balloon assembly includes asecond balloon; and a second connection lumen that extends from theproximal portion into the second balloon to permit transfer of a fluidtherebetween so as to independently inflate or deflate the secondballoon; a guarded zone disposed between the first and second balloonassemblies that is coupled to at least a first guarded zone lumen thatextends from the guarded zone to the proximal portion; an imagingcomponent that is disposed in the guarded zone and that is configured toimage an adjacent tissue zone of a patient; and a flexible, elongatebody joining at least the first and second balloon assemblies, theguarded zone, and the imaging component. In a preferred embodiment, thedevice further includes a guidewire lumen that extends from the distalportion to at least a position distal to the second balloon assembly.

In one embodiment, the imaging component is coupled to a connectionmedia lumen that extends from the proximal portion to a second positionwithin the guarded zone. In a preferred embodiment, the connection medialumen encompasses at least one electrical conduction wire either toprovide electrical power to the imaging component, to transmit datasignals between the imaging component and the proximal portion, or both.In another embodiment, the imaging device further includes a secondguarded zone lumen wherein the first guarded zone lumen permits transferof a fluid into the guarded zone and the second guarded zone lumenpermits transfer of a fluid from the guarded zone to a position distalto at least one of the first and second balloons. In a preferredembodiment, the imaging component includes at least a portion of anoptical coherence tomography device including an optical fiber orreflector and further including an optical fiber disposed in theconnection media lumen. In a more preferred embodiment, the imagingcomponent includes at least one ultrasound transducer. In another morepreferred embodiment, the ultrasound transducer is adapted to operate ina high frequency range of about 40 MHz to about 80 MHz.

In another embodiment, the first guarded zone lumen is adapted todeliver a therapeutic or diagnostic agent to the tissue zone. In anotherembodiment, the imaging device further includes an ablation devicedisposed in the guarded zone. In yet another embodiment, the imagingdevice further includes a distal port lumen that extends from theproximate portion to a position distal the first and second balloonassemblies. In another embodiment, the distal port lumen is configuredto deliver a therapeutic or diagnostic agent to the distal end when atleast one of the first and second balloons is inflated.

In a second aspect, the disclosure encompasses methods for imaging atissue zone in a patient including by inserting from a proximal zone, aflexible, elongate body including first and second inflatable zones thatare inflatable in vivo and an imaging component disposed in a guardedzone defined by a region between the first and second inflatable zones,to a distal position adjacent a tissue zone to be imaged; providingthrough an irrigation lumen, which extends between the proximal zone andthe guarded zone, an imaging fluid that is adapted to conduct a signaltherethrough that is emitted by the imaging component; and obtaining animage of the tissue zone with the imaging component.

In one embodiment, the image is obtained by selecting optical coherencetomography or high-resolution ultrasound imaging at a frequency range ofabout 40 MHz to about 80 MHz. In another embodiment, the method includesrotating a portion of the imaging component, i.e., a rotational element.In another embodiment, the method includes a phased-array, for example,by having the imaging component selected to include a phased-array. In apreferred embodiment, at least one of the images obtained does notcontain visible distortion at normal magnification.

In another embodiment, the obtaining the image is repeatedly conductedas the flexible, elongate body is advanced so that the imaging componentis adjacent to one or more additional tissue zones. In one embodiment,the method further includes treating the tissue zone by providing atleast one therapeutic agent through a treatment lumen that extends fromthe proximal zone to the guarded zone. In a preferred embodiment, thetreating is concurrent with the obtaining an image. In another preferredembodiment, the method further includes analyzing an obtained image toidentify a dissolvable material in the tissue zone, and selecting the atleast one therapeutic agent to treat the dissolvable material. In yet afurther preferred embodiment, the method further includes repeating theanalyzing, selecting, and treating to remove a plurality of dissolvablematerials from the tissue zone while the flexible, elongate body is invivo.

In another embodiment, the method further includes removing at leastsubstantially all fluid present in the guarded zone through anaspiration lumen that extends between the proximal zone and the guardedzone. In a preferred embodiment, the method further includes retainingan amount of fluid removed from the guarded zone for analysis, biopsy,or both. In yet another embodiment, the method further includes ablatingtissue in the guarded zone. In a preferred embodiment, the ablating andobtaining an image occur sequentially. In an alternative preferredembodiment, the ablating and obtaining an image occur concurrently.

In a third aspect, the disclosure encompasses a method for treating atissue zone in a patient including by inserting from a proximal zone, aflexible, elongate body including first and second inflatable zones thatare inflatable in vivo, to a distal position in a patient's vessel;inserting a treatment lumen that extends from the proximal zone to adistal portion of the flexible, elongate body that is distal to thefirst and second inflatable zones and adjacent the tissue zone to betreated; inflating at least one of the first and second inflatable zonessufficiently so as to block the vessel; and then treating the tissuezone with a therapeutic agent administered through the treatment lumenwhile at least one of the first and second inflatable zones is inflated.

In one embodiment, the therapeutic agent provided is selected to includeoxygenated particles in an amount sufficient to provide oxygen to thepatient distal to the flexible, elongate body. In another embodiment,the therapeutic agent is selected to include a dissolution agentsufficient to dissolve at least a portion of a dissolvable materialadjacent the tissue zone. In yet a further embodiment, the tissue zoneis selected from at least one of a vascular tissue, an esophagealtissue, a respiratory passage tissue, or an intestinal tissue, or acombination thereof. In one preferred embodiment, the method furtherincludes providing an imaging component disposed in a guarded zonedefined by a region between the first and second inflatable zones;providing through an irrigation lumen, which extends between theproximal zone and the guarded zone, an imaging fluid that is adapted toconduct a signal therethrough from the imaging component; and obtainingan image of the tissue zone with the imaging component. In a preferredembodiment, the method further includes removing at least substantiallyall fluid present in the guarded zone through an aspiration lumen thatextends between the proximal zone and the guarded zone. In oneembodiment, obtaining the image and the treating are concurrent. Inanother embodiment, obtaining the image and the treating are sequentialand the flexible, elongate body is repeatedly advanced to dispose theimaging component adjacent the treated tissue before obtaining an image.

In a fourth aspect, the disclosure encompasses an in vivo imaging systemincluding the imaging device described above; an interface moduleconfigured to connect with the imaging component; and an imageprocessing component in communication with the interface module.

In a fifth aspect, the disclosure encompasses a method of forming animaging device which includes providing a flexible, elongate body havingproximal portion and a distal portion; and disposing within theflexible, elongate body an imaging system which includes: a firstballoon assembly in a distal position, which includes a first balloonand a first connection lumen that extends from the proximal portion intothe first balloon to permit transfer of a fluid therebetween so as toindependently inflate or deflate the first balloon; a second balloonassembly in a proximal position relative to the first balloon assembly,which second balloon assembly includes a second balloon and a secondconnection lumen that extends from the proximal portion into the secondballoon to permit transfer of a fluid therebetween so as toindependently inflate or deflate the second balloon; a guarded zonedisposed between the first and second balloon assemblies that is coupledto at least a first guarded zone lumen that extends from the guardedzone to the proximal portion; and an imaging component that is disposedin the guarded zone and that is configured to image an adjacent tissuezone of a patient.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description. It shouldbe understood that different embodiments may be alternative oradditional, and that various embodiments discussed above can be combinedin various ways.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is best understood from the following detaileddescription when read with the embodiments, or examples, illustrated inthe accompanying figures. It is emphasized that various features are notnecessarily drawn to scale. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended. Anyalterations and further modifications in the described embodiments, andany further applications of the principles of the invention as describedherein are contemplated as would normally occur to one of ordinary skillin the art to which the invention relates.

Illustrative embodiments of the present disclosure, which form part ofthe present specification, will be described with reference to theaccompanying drawings, of which:

FIG. 1 is a diagrammatic schematic side view of exemplary in vivoimaging devices according to various embodiments of the presentdisclosure.

FIG. 2 is a diagrammatic schematic, partial cutaway side view of adistal portion of an imaging device according to an embodiment of thepresent disclosure.

FIG. 3 is a cross-sectional view taken along line 3-3 of a distalportion of the imaging device shown in FIG. 2, according to anembodiment of the present disclosure.

FIG. 4 is a diagrammatic schematic top down view of a fluid controllermodule according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Specific examples of componentsand arrangements are described below to simplify the present disclosure.These are, of course, merely examples and are not intended to belimiting. Any alterations and further modifications to the describeddevices, systems, and methods, and any further application of theprinciples of the present disclosure are fully contemplated and includedwithin the present disclosure as would normally occur to one of ordinaryskill in the art to which the disclosure relates. In particular, it isfully contemplated that the features, components, and/or methodsdescribed with respect to one embodiment may be combined with thefeatures, components, and/or methods described with respect to otherembodiments of the present disclosure. For the sake of brevity, however,the numerous iterations of these combinations will not be describedseparately.

Referring to FIG. 1, shown therein is an imaging device 100 according toan embodiment of the present disclosure that includes a flexible,elongate body 108 having a proximal portion 102 and a distal portion 104having a distal end 106. The flexible, elongate body 108 is typicallyformed of a plastic, polymer, or other flexible material, or combinationthereof and designed to be flexible to effectively traverse a patient'svessels without damage. In one embodiment, the flexible, elongate bodyis a catheter, while in others it is adapted for respiratorypassageways, etc.

The imaging device 100 includes in the distal portion 104 at least afirst balloon assembly 110 and a second balloon assembly 112, each ofwhich includes a balloon and respectively, a first connection lumen 126and a second connection lumen 124. The first and second connectionlumens 124, 126 may be used to transfer a fluid, which may be a gas or aliquid, between the proximal portion and each balloon. In low riskoperations where the balloon will is unlikely to tear, a gas may beused, while a liquid is preferred in any use where the fluid mightescape. These may be inflated sufficiently as shown to prevent theimaging device 100 from moving in vivo during imaging, treatment, orboth, and then deflated sufficiently to advance the imaging device 100as desired. When the first and second balloon assemblies 110, 112 areinflated, they define a guarded zone 115 disposed therebetween in theflexible, elongate body 100. The guarded zone 115 is coupled to at leasta first guarded zone lumen 120 that extends from the guarded zone to theproximal portion. This first guarded zone lumen 120 may be used totransfer fluid between the guarded zone 115 and the proximal portion102. The imaging device 100 may also include a guidewire lumen 130 thatextends from the distal portion to at least a position distal to thesecond balloon assembly to facilitate advancement of the flexible,elongate body 108.

The imaging device 100 can also include one or more connectors therein(not shown) in one embodiment that connect between a proximal portionand the imaging component 132 in the guarded zone 115. Optionally, butpreferably, the guarded zone is also coupled to at least a secondguarded zone lumen 122. In this embodiment as shown, the first guardedzone lumen can be used to irrigate and the second guarded zone lumen canbe used to aspirate fluid(s) between the guarded zone 115 and theproximal portion 102. When desired, this can advantageously permitremoval of a portion of the blood in the guarded zone 115 and optionallybut preferably replace it with an imaging fluid that is suitable for thetype of imaging to be conducted by the imaging component 132. Theimaging fluid can be any agent that permits high quality imaging, suchas water, saline, or another irrigant that is a solution or otherwisehas sufficiently few particles of a size that collectively causeinterference with the imaging component 132 when in operation, e.g.,blood. The imaging fluid is preferably substantially or entirely free ofparticles or other distortion-causing components, such as blood cells,ablated material, gaseous bubbles, or a combination thereof. Preferably,the entire guarded zone is replaced with an imaging liquid, or withsuitable blood after imaging is completed, to avoid leaving any gasbubbles behind in the vessel that could cause patient complications. Theimaging component 132 may be disposed in the guarded zone 115 in variouspositions using various techniques. As shown, the imaging component iscoupled to an outside surface of the second connection lumen as itpasses through the guarded zone 115. In other exemplary embodiments (notshown), the imaging component can be coupled to the first or secondguarded zone lumens 120, 122, arranged about an inner surface of theflexible, elongate body 108, coupled to one of the balloons or connectedbetween the balloons of the first and second balloon assemblies 110,112, or coupled to the guidewire lumen as it passes through the guardedzone.

The imaging component 132 can be used to image the interior tissue of apatient's vessel, such as a vascular region, respiratory region (e.g.,nasal or bronchial passage), digestive vessel (e.g., esophagus,intestine, etc.), or the like. Various types of imaging components maybe used. One example of a preferred imaging component 132 is an OCTdevice or a high-resolution ultrasound device. In another form, theimaging component 132 can collect information for spectroscopy or photoacoustic imaging. A forward looking device that scans forward into thevessel rather than outward from the axis towards the walls of the vesselcan also be used as an alternative or in addition to one that imagesperpendicularly to the longitudinal axis of the flexible, elongate body108. In one aspect, a forward-looking imaging system may be positioneddistal from balloon assembly 112 to assist with positioning the body 108(such as a catheter) while the imaging component 132 is included in theguarded zone 115. When the imaging component 132 is rotational, it istypically operably connected to a distal end of a driveshaft, which maybe included in a driveshaft lumen or be disposed in the first guardedzone lumen 220 with sufficient additional room for a fluid to betransferred through the lumen at the same time. In one preferred aspect,the driveshaft is disposed along with a liquid lubricant in the lumen220, which minimizes friction and heat from the driveshaft duringrotational operation. When the imaging component 132 is a solid-statedevice, also known as a phased-array, a plurality of ultrasoundtransducers are distributed around the circumference of the imagingcomponent 132 and connected to a set of transducer controllers adaptedto transmit an ultrasound pulse and receive the echo signal in a definedpattern. By stepping through a sequence of transmit-receive pairs, thesolid-state ultrasound system can synthesize the effect of amechanically scanned transducer element, but without moving parts.

The imaging component 132 disposed in the guarded zone 115 is configuredto image an adjacent tissue zone of a patient. The flexible, elongatebody 108 joins at least the first and second balloon assemblies 110,112, the guarded zone 115, and the imaging component 132. In anoptional, but preferred embodiment, the imaging device 100 also includesa distal lumen 128, which can be used to deliver a therapeutic agent toa location distal to the first and second balloon assemblies 110, 112even while inflated. Any available therapeutic agent may be delivered,but preferably the distal lumen 128 is of a comparable size to the otherlumens present. In one preferred embodiment, the therapeutic agentincludes a gas-filled agent, preferably an oxygenated agent, such asoxygen-containing particles. Distal oxygenation via introduction ofoxygen, such as oxygen-containing or other gas-containing particles todeliver oxygen or another gas to a location distal to the flexible,elongate body 100 while one or more of the inflatable zones 110, 112 isinflated enough to restrict or eliminate blood flow while inflated, canextend the time available for imaging using imaging component 132 or forany other reason. (See, e.g., “Injecting Oxygen Directly Into TheBloodstream Could Save Suffocating Patients,” Pop Sci., Jun. 27, 2012,http://www.popsci.com/science/article/2012-06/injecting-oxygen-filled-microparticles-bloodstream-could-buy-half-hour-suffocating-patients,which is incorporated herein in its entirety by express referencethereto.)

Another therapeutic agent that can be used in the guarded zone 115 orthrough the distal lumen 128 is a dissolving agent of one or morematerials, e.g., acids, etchants, or the like, or any combinationthereof, that can be used to dissolve deposits in the patient's tissuezone. Therapeutic agents may be administered in sequence, as well, totreat a newly exposed material in a tissue zone. Ablation or previoustreatment with a dissolving agent may expose new material in the tissuezone, which may differ from previously removed dissolvable (orablatable) material and may require a different therapeutic agent tomost effectively continue treatment. In another embodiment (not shown),the distal lumen 128 or another lumen can extend from the proximalportion 102 to the guarded zone 115 to deliver a therapeutic agent tothe guarded zone 115.

In another embodiment, an ablation device 134 is included in the guardedzone. The ablation device 134 can be coupled to a therapeutic lumen orat a distal end of the distal lumen 128 (each not shown) if desired, orpreferably can be coupled to the second guarded zone lumen 122 that isused for aspiration. The ablation device 134 can effectively be disposedin the guarded zone 115 or distal to the distal balloon assembly 112 andcoupled to the same type of components as noted herein for coupling theimaging component 132. The ablation device 134 and imaging component 132can be disposed on the same or different part of the imaging device 100.In addition, or in place of removal of fluid in the guarded zone 115,the second guarded zone lumen 122 can be used to remove materialloosened by the ablation device 134 when disposed in the guarded zone115, as is preferred, to increase clarity of any additional imagingconducted with the imaging component 132. The ablation device 134 mayuse any available ablation method or component, including withoutlimitation one or more lasers, electrical/cauterization, RF, ultrasound,and other suitable energy. Additional clear fluid, or remediatedaspirated fluid having ablated, dissolved, or other material that hassince been removed, can be irrigated into the guarded zone 115 throughthe first guarded zone lumen 120 or otherwise adjacent the ablationdevice 134 for further treatment.

Referring to FIG. 2, a distal section of the device 250 includes variouslumens in various embodiments of the present disclosure. The integratedimaging and therapeutic device 250 shown here includes a flexible,elongate body 200 that joins or at least retains these various lumens.The flexible, elongate body 200 can be advanced in vivo to a tissue zonein a patient through use of a guidewire 230 that extends from a distalportion to at least a position distal to the second balloon assembly. Inone embodiment, the guidewire extends through a guidewire lumen 230. Asshown, a distal lumen 228 delivers a therapeutic agent from a proximallocation 202 to a distal location 204 past the two balloon assemblies210, 212. The first and second balloon assemblies 210, 212 can beinflated and deflated through dedicated first and second connectionlumens 224, 226, respectively. A first guarded zone lumen 220 isincluded, although the optional but preferred second guarded zone lumen222 is depicted as well. When both first and second guarded zone lumens220, 222 are included, one may be adapted to irrigate the guarded zone211 between the first and second balloon assemblies 210, 212 while theother may be adapted to aspirate the guarded zone 211.

Additionally, as shown, a connection media lumen 234 may be included.The connection media lumen 234 may include one or more electricalconnectors, for example, to provide power to an imaging component,ablation component, or other equipment (not shown) in the guarded zonebetween the first and second balloon assemblies 210, 212. The one ormore electrical connectors in the connection media lumen 234 mayfacilitate transmission of control signals to the imaging or ablationcomponent, or both, as well as transmission of collected imaginginformation from the imaging component to a proximal position 202 forfurther processing and/or analysis. For example, one electricalconnector could be a microcable having a braided exterior with aplurality (e.g., 7) individual insulated electrical conductors. Theconnection media lumen 234 may additionally or alternatively include oneor more optical fibers, particularly where the imaging component 132 isadapted for optical coherence tomography, infrared, or other light-basedimaging. In some embodiments, the connection media lumen 234 extendsthrough the guarded zone and joins the imaging component 132, theoptional ablation device 134 when present, or both. The processingsystem typically remains outside of the patient. The processing systemuses the data received from the imaging component 132 to create animage. The image can be displayed to a medical professional in realtime, for example, as the flexible, elongate body moves through thepatient's vessel or as in situ treatment progresses. This allows themedical professional to find various occlusions or other irregularitiesthat may exist throughout the patient's vessel. The number of wires,cables, or optical fibers typically depends on the type of imagingcomponent and the manner in which data is transferred (or stored foranalysis after removal of the device) from the imaging component to theexternal processing system(s).

In one embodiment (not shown), one or more of the lumens such as theconnection media lumen 234 may be overmolded partially or entirely intothe flexible, elongate body 200. The connection media lumen 234 may beor may include one or more electrical leads that extend between theproximal portion and the imaging component in the guarded zone. Althoughnot shown, when any component such one or more electrical leads is builtinto part of the flexible, elongate body 200, the electrical leads maydefine their own connection media lumen 234.

FIG. 3 is a cross-section of a proximal cross-section of the distalportion of the flexible, elongate body 200 shown in FIG. 2. As shown,the cross-section includes a guidewire lumen 230, a distal port lumen228, first and second guarded zone lumens 220, 222 that can be used forirrigation and aspiration of fluids (which can also be referred to asguarded zone fill and guarded zone vent lumens), first and secondconnection lumens 224, 226 that extend between a proximal portion of theflexible, elongate body 200 to a distal position coupled with the firstand second balloon assemblies, respectively. Also included is aconnection media lumen 234, which although not shown can include one ormore electronic conduction wires optionally with additional otherconnections therein. The one or more electronic conduction wires whenincluded in a preferred embodiment provide electric power to the imagingcomponent, and to the optional ablation device when present. The one ormore electronic conduction wires also facilitate transmission of datasignals between the proximal portion or end, where an interface modulemay be disposed to receive and process data signals relating to theimaging or operation of the ablation device and any associated sensorsincluded therewith in the flexible, elongate body.

In one embodiment, one of the first and second guarded zone lumen 220,222 is used to provide a therapeutic or diagnostic agent to the tissuezone in the guarded zone 211. A preferred diagnostic agent includes anirrigant fluid, preferably a liquid. The other of the first and secondguarded zone lumens is used to aspirate blood or otherdistortion-causing fluid from the guarded zone 211. In one embodiment,the distortion-causing fluid includes ablated material removed fromtissue with the ablation device 134. When one of the first and secondguarded zone lumens 220, 222 administers a therapeutic agent aspreviously discussed, the imaging component and guarded zone 211 may beadjacent to the tissue zone being treated and imaged. In an alternativeembodiment, the tissue zone being treated may be distal to the flexible,elongate body 200, which may be advanced after treatment to arrange theguarded zone near the treated tissue zone. This is an exemplarytechnique that can permit continuous treatment and imaging, because theimaging will occur shortly after treatment as the flexible, elongatebody 200 is advanced.

In various embodiments directed to the present guarded zone imagingdevices, a distal lumen may be incorporated to deliver a therapeuticagent and an imaging component or imaging system to accurately access,assess, and treat vessels and/or other tubular structures within apatient. For example, embodiments of the present disclosure areconfigured to dissolve deposits in a patient vessel or to deliveroxygenated particles to extend the time for in-depth imaging asdiscussed herein. Some of the embodiments disclosed herein comprise dualballoon assemblies that incorporate an imaging component 132 such as, byway of non-limiting example, transducers and optical devices operable toperform sensing modalities such as IVUS, optical coherence tomography(OCT), photo acoustic inspection, infrared imaging, and spectroscopy.Preferably, the imaging is OCT or high-frequency ultrasound or IVUS,i.e., at a frequency of greater than about 40 MHz to about 80 MHz, morepreferably 45 MHz to about 75 MHz. In some embodiments, the imagingcomponent 132 may be oriented generally perpendicular to thelongitudinal axis of the flexible, elongate body 100 for side lookingimaging while other embodiments may employ axially oriented imagingsensors that provide forward looking imaging ahead or to the side(s) ofthe distal balloon assembly. Thus, the embodiments disclosed herein mayadvantageously allow a medical professional to access, assess, and treatdiseased vessels and related tissues in a patient, with more imagingvisibility and over a longer time in vivo than offered by some prior artcatheters and similar devices.

An exemplary fluid controller module 402 is shown in FIG. 4 operativelycoupled with a catheter 400 having first and second balloon assemblies410, 412 in one aspect of the invention. While the fluid controllermodule 402 is optional, it may be preferred in some embodiments. Thefluid controller module 402 may be arranged to include one or more ofthe following: a reservoir 406 for an irrigating fluid and/ortherapeutic agent; a reservoir for an oxygenating fluid 408. To beclear, in this embodiment, the therapeutic agent may be a dissolvingagent and the oxygenating agent is a separate component (i.e., anadditional therapeutic agent). A timer/controller 404 may manage thevalve sequences to automate or partially automate the fluid control atset times after initiation or under control of a medical professional. Afluid reservoir 414 may be included, either to store additionalirrigating fluid, therapeutic agent, or oxygenating fluid, preferablyseparately in sub-reservoirs (not shown) or in sequence, or simply toprovide the fluid in a location more closely adjacent to the catheter400 itself for any or all of these fluids, which may facilitate controlwhen inserting a specific amount therein. The fluid controller module402 may also preferably include valves to facilitate control, which mayalternatively include connectors to plug in external fluid flow supply.The valves may include, for example, balloon fill valves 416, guardedzone fill/purge (irrigate/aspirate) valves 418, oxygenating fluid valve420, or the like. Preferably, pressure monitoring instrumentation, fluidflow monitoring instrumentation, or both may be included, such as in thedepicted pressure and flow monitoring instrumentation panel 422. Variousother configurations may be envisioned in different embodiments despitenot being depicted in FIG. 4.

Methods of Use: Imaging, Treatment, and Integrated Imaging and Treatment

The imaging component can take and store images taken within a livingbody for retrieval after removal of the imaging device from the patient.Preferably, however, the imaging component is operatively coupled withan interface system external to the patient. It is possible tooperatively couple these to transmit signals, such as by RF or othermechanisms, but preferably data signals representative of imaginginformation collected by the imaging component are transmitted via theconnection media lumen between the imaging component and the proximalportion where the interface system may process such signals to provideimages readily understandable by a medical professional, and in someembodiments even the patient.

Preferably, the first and second balloons are deflated at leastsufficiently or entirely to facilitate advancing the flexible, elongatebody in vivo. It should be understood that by “advancing” it istypically meant the catheter is moved into the body away from a point ofaccess into the body. In one embodiment, however, the term also meansthe catheter may be moved proximally towards or distally from the pointof access.

A tissue zone in a patient may be imaged by inserting a flexible,elongate body that includes first and second inflatable zones that areinflatable in vivo, and an imaging device disposed in a guarded zonedefined by a region between the first and second inflatable zones, froma proximal position or zone to a distal position adjacent a tissue zoneto be imaged. By disposing an imaging component in such a guarded zone,this permits the blood or other fluid to be replaced with an imagingfluid that is preferably clear (to the imaging component signals)irrigated through an irrigation lumen, which extends between theproximal zone and the guarded zone, and then obtaining an image of thetissue zone with the imaging component of the device. Thisadvantageously can provide clearer images, particularly using imagingmodalities that provide poor quality without the proper imaging fluid,such as OCT and high-frequency ultrasound. The imaging can be achievedwith rotational ultrasound transducers or optical fiber or reflector, orwith a phased-array arrangement of such equipment as part of the imagingcomponent. Preferably, one or more images so obtained do not containvisible distortion at normal magnification, such as speckles. Multipleimages can be obtained while the flexible, elongate body is fixed inplace, or while it is advanced so that the imaging device is adjacent toone or more additional tissue zones. In a preferred embodiment, at leastsubstantially all, or all, fluid present in the guarded zone is removedthrough an aspiration lumen that extends between the proximal zone andthe guarded zone. This can permit removal of distortion-causing fluid,which may be fluid including ablated material, blood, etc. or acombination thereof In one embodiment, the removed fluid can be retainedfor analysis, biopsy, or both.

Either concurrent with, or in various sequences with, the imaging, thedisclosure includes embodiments that involve treating the patient'stissue zone by providing at least one therapeutic agent through atreatment lumen that extends from the proximal zone to the guarded zoneor to a position distal both the first and second balloon assemblies.Preferably, this occurs with the flexible, elongate body in vivo toavoid time-consuming imaging, removal, treatment, and then re-insertionfor additional imaging. Treatment can take various forms as disclosedherein, including providing oxygenated particles, such as nanoparticles,to a position distal to the entire imaging device to provide oxygen totissues that would otherwise lack oxygen due to the cessation of fluidflow past the inflated zones of the flexible, elongate body wheninflated. In a vascular vessel, this can permit oxygenation of tissuesto extend the time for imaging or other treatment.

In another embodiment, an obtained image or images can be analyzed toidentify a dissolvable material in the tissue zone, and at least onetherapeutic agent can be selected to treat the dissolvable materialconcurrently or in sequence. This may be referred to as selectivedissolution, which is facilitated by constant, high resolution imagingto help analyze the materials to be dissolved or removed (e.g., throughablation) in the tissue zone. In one embodiment, the process can berepeated as needed by analyzing, selecting, and treating in sequence toremove a plurality of dissolvable materials from the tissue zone whilethe flexible, elongate body is in vivo. In a further aspect, theprocessing system includes a database of tissue information allowingreceived signals to be compared to perform tissue characterization.Tissue characterization information can be displayed to the user toaccess the progress of treatment and any potential adverse events. Thus,as each dissolvable material is identified by imaging, an appropriatetherapeutic agent can be provided to the tissue zone to be treated,either in the guarded zone adjacent the imaging component or distal tothe entire device.

In another embodiment, which may be used in conjunction with the imagingcomponent, with or without associated administration of a therapeuticagent, an ablation device may ablate tissue in the guarded zone. Thisablation may occur concurrently or sequentially with imaging. Varioussequences can be used, such as imaging followed by ablation; imagingfollowed by ablation repeatedly; imaging, ablation, and imaging toconfirm success; etc. Similarly, other sequences can include imaging,administration of a therapeutic agent, imaging; imaging, administrationof a therapeutic agent, ablation, imaging; imaging, administration of atherapeutic agent, imaging, administration of a second therapeuticagent, which may be the same or different; etc. When the therapeuticagent includes one or more dissolvable materials, these may beadministered in the guarded zone through the first guarded zone lumen orotherwise, as well as at a position distal to the flexible, elongatebody, or both. The tissue zone to be imaged, or imaged and treated(including ablation), is selected from at least one of a vasculartissue, a respiratory passage tissue, or a digestive tissue (includingesophageal, intestinal, etc.), or a combination thereof. When imagingand treating are concurrent, additional similar sequences can be used.For example, the imaging may be constant and the treatment may beadministered with the outcome imaged to evaluate for additionaltreatment. When the image and the treating are sequential and thetreating occurs at a distal location to the flexible, elongate body, thebody may be repeatedly advanced after each treatment to dispose theimaging component adjacent the treated tissue before obtaining one ormore images.

In vivo imaging systems are also included in the disclosure herein.These may include an imaging device that is adapted to intravascular,intra-bronchial, intra-nasal, or any other suitable vessel imaging.Preferably, the device is an integrated imaging and treatment device. Innon-fluid filled passages, the guarded zone may be filled with anirrigant fluid, such as saline, to facilitate transmission of signals.For example, introduction of fluid temporarily to a passageway in theguarded zone can permit ultrasound waves to propagate from thetransducer(s) to the tissue of interest, and the fluid can later beremoved concurrently or sequentially with removal of the catheter fromthe tissue zone. The imaging system thus includes the imaging devicealong with at least an interface module configured to connect with theimaging device, and image processing component (software, hardware, orboth) in communication with the interface module. The interface moduleand image processing are typically positioned ex vivo and connectedelectronically or optically to the imaging component in the imagingdevice.

Methods of forming the imaging devices herein are also included asdescribed herein and as would be readily understood by those of ordinaryskill in the art based on the imaging devices and systems, and relatedguidance, provided herein.

Persons of ordinary skill in the art will recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

1. (canceled)
 2. A catheter, comprising: a flexible elongate bodyconfigured to be positioned within a patient, the flexible elongate bodycomprising a proximal portion, a distal portion, and an outer profile; afirst balloon coupled to the distal portion; a second balloon coupled tothe distal portion, wherein the second balloon is spaced from the firstballoon along a length of the flexible elongate body; an operativeelement coupled to the distal portion and positioned along the length ofthe flexible elongate body between the first balloon and the secondballoon; wherein the flexible elongate body further comprises: a guardedzone positioned between the first balloon and the second balloon,wherein the operative element is aligned with the guarded zone along thelength of the flexible elongate body to image, treat, and/or diagnose atissue zone adjacent to the guarded zone; an operative lumen extendingwithin the outer profile from the proximal portion to the operativeelement and configured to facilitate imaging, treatment, and/ordiagnosis of the tissue zone by the operative element; and a guidewirelumen extending within the outer profile and adjacent to the operativelumen along at least a portion of the length of the flexible elongatebody.
 3. The catheter of claim 2, wherein the guidewire lumen extends toa position distal of the first balloon and the second balloon.
 4. Thecatheter of claim 2, wherein the operative element is an imagingcomponent.
 5. The catheter of claim 4, wherein the flexible elongatebody further comprises an electrical conductor disposed within theoperative lumen, and wherein the operative element comprises anultrasound transducer in communication with the electrical conductor. 6.The catheter of claim 4, wherein the flexible elongate body furthercomprises an optical fiber disposed within the operative lumen, whereinthe operative element comprises an optical coherence tomography (OCT)device in communication with the optical fiber.
 7. The catheter of claim2, wherein the operative element is a therapeutic component.
 8. Thecatheter of claim 7, wherein the flexible elongate body furthercomprises an electrical conductor disposed within the operative lumen,wherein the operative element comprises an ablation device incommunication with the electrical conductor.
 9. The catheter of claim 7,wherein the operative element comprises an opening of the flexibleelongate body in communication with the operative lumen, wherein theoperative lumen is configured to deliver a therapeutic agent into thepatient via the opening.
 10. The catheter of claim 2, wherein theoperative element comprises an opening of the flexible elongate body incommunication with the operative lumen, wherein the operative lumen isconfigured to transfer fluid into or out of the tissue zone.
 11. Thecatheter of claim 10, wherein the flexible elongate body furthercomprises a further lumen configured to transfer fluid into the tissuezone, and wherein the operative lumen is configured to transfer fluidout of the tissue zone.
 12. The catheter of claim 2, wherein the firstballoon and second balloon are inflatable independently of each other.13. The catheter of claim 12, wherein the flexible elongate body furthercomprises: a first connection lumen that extends from the proximalportion to the first balloon to permit transfer of fluid therebetween soas to inflate or deflate the first balloon; and a second connectionlumen that extends from the proximal portion into the second balloon topermit transfer of fluid therebetween so as to inflate or deflate thesecond balloon.